HS-IRBs News April 2012

New Investigators Page Now Available

A new page has been added to the HS-IRBs website specifically for new investigators. Information for New Investigators includes general step-by-step guidance regarding the IRB review process and links to a variety of resources. In addition to the resources available on the website, new investigators are strongly encouraged to schedule a consultation before submitting their first application to the HS or MR-IRB.  To schedule a consultation, please fill out the request form available here: https://ictr.wisc.edu/irb.

Study Team Response Timelines in ARROW

Timelines for study teams to respond to issues raised by the IRB has now been standardized. Study teams have 90 days to respond to pre-review, modifications requested after an IRB meeting, and IRB deferral requests. Study teams will receive email reminders to submit a response at 30 and 60 days after issues have been sent to the study team.

After 90 days with no response from the study team, submissions will automatically transition to the IRB Withdrawn state. Study teams then have 12 months to request reactivation before the submission is automatically archived. Study teams who repeatedly time out and request reactivation may be asked to submit a new application.

Update: Checking Human Subjects Research Training/CITI Certification in ARROW

The Record Human Subjects Training Snapshot activity is now live in ARROW. This means study teams can check the training certifications for all key personnel listed on a specific study. Study teams should use this activity before submitting new applications or personnel changes. For instructions on how to use this new activity, please see [Link for document 23550 is unavailable at this time.]. Please also keep the following in mind:

• New submissions and personnel changes cannot be approved until all study team members have completed the required human subjects research training course and their certifications are current.
  
• If a study team member's training information appears to be inaccurate or incomplete in the list generated by the Record Human Subjects Training Snapshot, please email askarrowirb@medicine.wisc.edu. Training information may need to be manually updated by the HS-IRBs Office for study team members who took the training without using their UW-Madison netID and password.
• The current training lookup database will continue to be updated and can be used to look up certifications on an individual basis.
• Although completion of Good Clinical Practice training is recommended, it is NOT a substitute for human subjects research training.
  
• For more information on training requirements, see [Link for document 22595 is unavailable at this time.] .

Reviewing IRB Correspondence

Study teams are reminded of the need to review all correspondence from the HS-IRBs, including approval letters. Correspondence can include additional requirements that must be met by the study team. Study teams who do not meet the requirements included in IRB correspondence may need to submit a report of potential noncompliance. Study teams who have questions about letters they receive from the IRB should contact the IRB staff reviewer assigned to that submission for additional guidance.

Reminder: What to Do With Multiple Submissions for the Same Study

Study teams often ask how they should handle multiple submissions (e.g., change of protocol + continuing review + reportable event) for the same study. Please see I have a change of protocol and a continuing review coming up. Which should I submit first? for some tips on what to submit when if multiple submissions are pending for the same study. Study teams also are encouraged to call the HS-IRBs Office for advice.

Finding the IRB Meeting Date for Submissions in ARROW

After a submission is scheduled for an IRB meeting, the history tab is currently not displaying the specific IRB meeting date. The meeting date is displayed in the top portion of the submission workspace for all initial review applications. For a continuing review, full change of protocol, or reportable event, study teams can contact the staff reviewer assigned to that submission to find out to what meeting it has been assigned. In general, however, full continuing reviews and full changes of protocol are assigned to meetings about 2 weeks in advance of the meeting date; some continuing reviews may be assigned up to a month in advance. Reportable events that require review by the full IRB may be scheduled 1-2 weeks in advance of the meeting date. In the near future, ARROW will be updated to display the meeting date in the submission workspace for all submissions.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.

• Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
• General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email asktheirb@medicine.wisc.edu. These are the quickest ways to get help with general questions.
• Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
• Help with single IRB review and reliance questions, email irbreliance.wisc.edu.

• Assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
• Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
• WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
• Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
• Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.